Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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This is an issue the Government and the new politics urgently has to do something about. The Minister is aware that in the past few weeks, we have had two instances where people who are ill, often with life-threatening illnesses or seriously disabling illnesses, are not able to access certain drugs because of price, rather than the question of their medical efficacy or how they could help people who are sick, suffering or, in some cases, in life-threatening situations.

That is just not acceptable.

Orkambi was mentioned earlier today in the case of sufferers of cystic fibrosis, of which there is a very high instance in this country. The National Centre for Pharmacoeconomics stated it should not be funded at "the submitted price"; therefore, it is price which determines whether ill people will receive a drug that could make a real difference to their health and quality of life. Last week we had the issue of the availability of pembro for those with melanoma. There has now been movement on this issue, but there had to be a fight over it and it is only occurring because there was an outcry. Last year, with others, I raised the issue of the availability of Fampyra. I had received representations from people with MS, whom this drug assisted in being able to physically walk, but it was not available for them because of price.

It is utterly obscene - that is not too strong a word to use - that the profit line of incredibly profitable big pharma corporations determines whether people will receive life-saving medicines or drugs or medicines that could make an extraordinary difference to their quality of life. Another example is Harvoni, a drug for sufferers of hepatitis C. This issue has been brought to my attention in the past week or two and I do not know whether it has appeared in the public debate. It highlights another aspect of the debate. The cost of Harvoni here is 45 times higher than in Australia because of where we source it and the profiteering of the company which produces it. There are versions of these drugs which are exactly the same, but we pay top dollar,= and because of the price, we either pay too much or are not willing to pay the money.

This raises another issue. To what extent is the State looking for value for money and the cheapest versions of these drugs? We have advocated as our policy that there be a State pharmacy, the responsibility of which would be to find the cheapest versions of these drugs or else - this is important as I said earlier - we should produce them ourselves. There is no reason we could not do this. We have thousands of people and in some areas we are producing generic and much cheaper versions of drugs. We should expand this substantially, but there has been no serious push to do so.

Some of the price contrasts are absolutely extraordinary. In the United Kingdom 16 paracetamol tablets coss 35 cent. In Boots in Ireland they cost 99 cent, almost three times as much, and in Tesco, €1.55. I am not sure how much the State pays, but the point is it is an absolutely tiny fraction of the cost, even in the United Kingdom for paracetamol. In Ireland, in the case of Harvoni which I mentioned, the cost is €45,000 for a course of 12 tablets. From the hepatitis C buyers club in Australia the cost €1,000 for the same course. This is crazy stuff. I appeal to the Government and the Minister of State. This is an issue we must address as a matter of urgency for the sake of sick and vulnerable people and to achieve value for money for the State which spends €2 billion a year on medicines via the HSE.

Helen McEntee (Meath East, Fine Gael)
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I thank the Deputy for raising this very important issue which has featured in the media quite a lot in recent days in the context of developments in the provision of new cystic fibrosis and cancer drugs. Nobody should have to pay 45 times more than what is paid elsewhere. It is not right. There should always be equal access.

Decisions on the reimbursement of new drugs are matters for the HSE. They are not political decisions, as much as we would sometimes like them to be. Every drug undergoes a scientific and evidence based assessment in line with the HSE's statutory obligations. In many cases, the prices companies seek to charge are most definitely too high and, as a result, the product does not deliver health benefits in a cost effective manner. Unfortunately, we must look at what is cost effective. I know that the Deputy is not suggesting the HSE should simply accept the first price proposed by manufacturers for their products, regardless of their clinical benefits or cost effectiveness.

As with all new drugs developed, the HSE must follow a process. I understand how patients and their families must feel in these circumstances as they await a decision by the HSE on reimbursement. I dealt with a similar matter when a gentleman in my constituency needed a life-saving drug which cost too much. This is something we see all too frequently, which is why I am eager to ensure the process is concluded as efficiently as possible for each drug.

Yesterday the National Centre for Pharmacoeconomics, NCPE, published a recommendation that the cystic fibrosis drug Orkambi not be reimbursed by the HSE, as it was not considered cost-effective at the price of almost €160,000 per patient per year as submitted by the manufacturer. The high number of people who require it means that the cost is absolutely astronomical. The NCPE estimates the cost-effective price in this instance as being closer to €30,000, a significant difference. It estimates the five year gross budget impact of reimbursing Orkambi at more than €390 million and notes the significant opportunity cost associated with reimbursing the drug. Every additional euro paid to pharmaceutical companies is a euro less for investment in other critical health services and public services generally.

This is not the end of the reimbursement process. The HSE will now enter negotiations with the manufacturer to seek significant price reductions. It will then consider the outcome of these negotiations, together with the NCPE's recommendation, in making a final decision on reimbursement. I welcome the confirmation by the company to the NCPE this morning that it will continue to provide the drug for Irish patients who are involved in an expanded access programme until the issue of reimbursement is finalised in Ireland.

Two new cancer drugs have also been discussed by the HSE and in the House in recent days. I welcome yesterday's decision by the HSE to approve Pembrolizumab for reimbursement and I am sure this news will be welcomed by patients affected and their families. For the second drug, Nivolumab, I understand the assessment process is ongoing. I welcome the supplier's decision to extend its compassionate access programme for patients with advanced lung cancer to the end of June 2016 and the confirmation that all patients currently receiving treatment under the programme will continue to receive it.

The single biggest challenge in the assessment of new drugs for reimbursement is, as we have discussed, presented by the very high prices sought by suppliers. Let me be very clear - the process followed by the HSE is scientific, evidence-based and designed to deliver the best health outcomes for the patients in a cost effective manner. It is essential that the HSE have the support of everybody in the House in its efforts to achieve the very best result for Irish patients.